A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol (A5091031).

NCT00267280

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, , United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hyperlipidemia, Dyslipidemia, Hypercholesterolemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- eligible for statin treatment for LDL cholesterol by NCEP guidelines

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Women who are pregnant or lactating, or planning to become pregnant.


- Subjects taking any drugs known to be associated with an increased risk of myositis in
combination with HMG-CoA reductase inhibitors.


- Subjects with significant liver or kidney disease or significant heart failure.

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Hyperlipidemia, Dyslipidemia, HypercholesterolemiaA Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol.
NCT00267254
  1. Birmingham, Alabama
  2. Mobile, Alabama
  3. Mesa, Arizona
  4. Phoenix, Arizona
  5. Tempe, Arizona
  6. Little Rock, Arkansas
  7. Los Angeles, California
  8. San Diego, California
  9. Santa Rosa, California
  10. Boynton Beach, Florida
  11. Melbourne, Florida
  12. Merritt Island, Florida
  13. Palm Bay, Florida
  14. Safety Harbor, Florida
  15. Tampa, Florida
  16. Chicago, Illinois
  17. Newton, Kansas
  18. Topeka, Kansas
  19. Wichita, Kansas
  20. Madisonville, Kentucky
  21. Boston, Massachusetts
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  24. Portage, Michigan
  25. Troy, Michigan
  26. Minneapolis, Minnesota
  27. Kansas City, Missouri
  28. St. Louis, Missouri
  29. Butte, Montana
  30. Lincoln, Nebraska
  31. Las Vegas, Nevada
  32. Concord, New Hampshire
  33. Trenton, New Jersey
  34. Cooperstown, New York
  35. East Syracuse, New York
  36. Rochester, New York
  37. Charlotte, North Carolina
  38. Cincinnati, Ohio
  39. Clinton, South Carolina
  40. Cordova, Tennessee
  41. Memphis, Tennessee
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  43. Dallas, Texas
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  46. Payson, Utah
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ALL GENDERS
18 Years+
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MULTIPLE SITES
Hyperlipidemia, Dyslipidemia, HypercholesterolemiaA Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol (A5091031).
NCT00267280
  1. Birmingham, Alabama
  2. Mesa, Arizona
  3. Alhambra, California
  4. Inglewood, California
  5. Los Angeles, California
  6. Santa Ana, California
  7. Wilmington, Delaware
  8. Fort Lauderdale, Florida
  9. Hollywood, Florida
  10. Jacksonville, Florida
  11. Merritt Island, Florida
  12. Pensacola, Florida
  13. Vero Beach, Florida
  14. Winter Park, Florida
  15. Atlanta, Georgia
  16. Conyers, Georgia
  17. Woodstock, Georgia
  18. Hinsdale, Illinois
  19. La Grange, Illinois
  20. Park Ridge, Illinois
  21. Springfield, Illinois
  22. Kansas City, Kansas
  23. Lexington, Kentucky
  24. Baltimore, Maryland
  25. Bethesda, Maryland
  26. Elkton, Maryland
  27. Flint, Michigan
  28. Springfield, Missouri
  29. Lawrenceville, New Jersey
  30. Albany, New York
  31. Seaford, New York
  32. Charlotte, North Carolina
  33. Cincinnati, Ohio
  34. Mansfield, Ohio
  35. Hillsboro, Oregon
  36. Beaver, Pennsylvania
  37. Flourtown, Pennsylvania
  38. Philadelphia, Pennsylvania
  39. Yardley, Pennsylvania
  40. Greenville, South Carolina
  41. Collierville, Tennessee
  42. Kingsport, Tennessee
  43. Knoxville, Tennessee
  44. North Richland Hills, Texas
  45. Spring, Texas
  46. Salt Lake City, Utah
  47. West Jordan, Utah
  48. Richmond, Virginia
  49. Bellevue, Washington
  50. Puyallup, Washington
  51. Tacoma, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol (A5091031).
Official Title  ICMJE A Phase 3, Open-Label, Multisite, Randomized, Parallel Group Study of the Efficacy and Safety of Fixed Combination Torcetrapib/Atorvastatin Administered Once Daily (QD) Compared to Simvastatin for 6 Weeks in Subjects With Hypercholesterolemia (A5091031)
Brief Summary

The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of cholesterol medications to see how the different treatments compare to one another.

Detailed Description For additional information please call: 1-800-718-1021
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hyperlipidemia
  • Dyslipidemia
  • Hypercholesterolemia
Intervention  ICMJE
  • Drug: torcetrapib/atorvastatin
  • Drug: simvastatin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: December 19, 2005)
640
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • eligible for statin treatment for LDL cholesterol by NCEP guidelines

Exclusion Criteria:

  • Women who are pregnant or lactating, or planning to become pregnant.
  • Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors.
  • Subjects with significant liver or kidney disease or significant heart failure.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00267280
Other Study ID Numbers  ICMJE A5091031
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP